Kornimate/medical-research-clean huggingface dataset:
expanding access to mtbi treatment for veterans and service members with co-occurring substance use

Conditions: Concussion, Mild Traumatic Brain Injury; Brain Injury; Traumatic Brain Injury; Substance Use; Substance Use Disorder (SUD)

Summary: the purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs. participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

this pragmatic clinical trial will (1) assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program (iop) and at a 6-month follow-up comparing service members and veterans (sm/vs) with mild traumatic brain injury (mtbi) + substance use (su) and a tbi -control group; and (2) assess su-related outcomes at the end of iop treatment and durability of su outcomes at 6-months follow-up among sm/vs with co-occurring su. analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders, will be used to refine and disseminate a scalable approach to treating individuals with mtbi and co-occurring su.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * us military service member or veteran * diagnosis of mild traumatic brain injury (mtbi) and/or repetitive head impact/blast exposures * participating in the share military initiative intensive outpatient program exclusion criteria: * history of brain injury other than mtbi or progressive neurological disorder * active psychosis * not able to provide consent

Keywords: concussion mild traumatic brain injuty brain injury substance use substance use disorder military service members veterance interdisciplinary intensive outpatient program neurorehabilitation
cytokine persistence as a marker of inflammation in the at risk, low socioeconomic status pediatric population

Conditions: Obstructive Sleep Apnea of Child

Summary: the investigators wish to study the role of persistent markers of inflammation in executive function in young children during critical periods of synaptogenesis (ages 2-3). while the role of markers of inflammation have been validated in the pathogenesis in multiple disorders in the adult population, their study in pediatrics is limited. the investigators therefore propose that demonstration of persistent cytokine inflammatory markers in this preliminary study will allow larger studies to proceed.

obstructive sleep apnea (osa) is a common multisystem disorder, affecting up to 10% of the pediatric population. there is scant data about osa and adenotonsillectomy (at) outcomes in the very young (ages 1-3). young children with moderate/severe osa are often underprivileged, low socioeconomic status (ses) minorities with limited access to care. further complicating the problem is that african american children may suffer a higher preoperative and post-at burden of disease, with greater negative consequences to these vulnerable children. up to 75% of children with osa continue to have sequelae of the disease post-at. these include poor school performance, delayed speech, inattention, and long term neurocognitive dysfunction. it has been demonstrated that younger patients (below the age of 3) have larger tonsils and stunted growth on presentation for at. more telling is that younger children face greater morbidity from the procedure, including respiratory complications, postoperative bleeding, and perioperative anoxic/hypoxic injury as validated by multiple studies. a recent study studied watchful waiting versus early at in two groups of patients aged 5-9 without severe osa. the findings indicated that early at improved respiratory and quality of life indices without corresponding improvement in attention or cognitive function as assessed by neuropsychological testing 7 months post intervention. so it leads to the further question of whether children with severe osa truly benefit from the procedure at all, and whether there maybe a trend towards harm. in this particular scenario, the investigators are hypothesizing that serum based biomarkers in the form of cytokines are of significant diagnostic benefit in demonstrating ongoing inflammation. therefore, the surgical stimulus and consequent stress response in the form of centrally mediated cytokines and inflammatory mediators demands study. these has been well analyzed with adult acute and chronic pain, and have been associated with neurocognitive impairment, but have not been studied as a neurocognitive biomarker in the pediatric population. children from lower ses, with less stable social environments, or other cultural/linguistic barriers are higher risk and urgently require study.

Eligibility criteria:
inclusion criteria: osa for adenotonsillectomy - exclusion criteria: -
color masking potential of bioactive and icon materials

Conditions: White Spot Lesion of Tooth

Summary: the non cavitated white-spot lesion (wsl) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. the resin infiltration material (icon, dmg, america) is considered to be the gold standard resin infiltrationmaterial used for wsl treatment. it is an efficient material in arresting wsls and has high favorable esthetic recovery. furthermore, biomaterials like bioactive glass adhesives hi-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. the hypotheses of this study are: 1. there will be no differences in color masking effect on wsls managed by bioactive glass adhesive or icon resin infiltration. 2. there will be no significant addition of mineral content into wsls after treating it with bioactive glass adhesive hi-bond universal or with icon.

after sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with icon; and 75 other teeth will be treated with hi-bond universal\]. split mouth study design involves treating wsls in two different quadrants in each participant. treatments will be done according to manufacturer's instruction. the wsls in the teeth of one quadrant will receive treatments with the icon (dmg, america) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive hi-bond universal (mediclus, south korea). before receiving the treatment, the wsls will be tested at baseline by quantitative light-induced fluorescence (qlf) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.

Eligibility criteria:
inclusion criteria: patients with teeth and wsl fullfiling the following criteria will be included in the study: 1. anterior and premolar maxillary and mandibular teeth. 2. teeth with no previous restorations. 3. post-orthodontic white spot lesions wsl with no adjacent restorations in the same tooth. 4. wsl on labial surfaces of maxillary or mandibular anterior and premolars teeth. exclusion criteria: the following will be excluded from the study, 1. cavitated enamel surface that requires direct composite restorations. 2. presence of developmental enamel defects on the proposed teeth. 3. diabetic patients and patients with metabolic syndrome. 4. pregnant ladies. 5. smoker patients.

Keywords: resin infiltration incipient lesion bioactive material icon infiltration resin
hyperpolarized carbon c 13 pyruvate magnetic resonance spectroscopic imaging in predicting treatment response in patients with prostate cancer

Conditions: Prostate Adenocarcinoma; PSA Level Greater Than Ten; Stage IIB Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Summary: this phase ii trial studies how well hyperpolarized carbon c 13 pyruvate magnetic resonance spectroscopic imaging works in predicting treatment response in patients with prostate cancer. hyperpolarized carbon c 13 pyruvate magnetic resonance spectroscopic imaging may help to accurately predict how prostate cancer patients will respond to standard therapy (abiraterone and apalutamide).

primary objective: i. to assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-c pyruvate magnetic resonance spectroscopic imaging (mrsi), including key performance indicator (kpl), which assesses the rate of conversion of 13-c pyruvate to 13-c lactate in the tissue of interest, using a test-retest study design. secondary objective: i. to provide initial assessment of the sensitivity and specificity of hyperpolarized 13-c-pyruvate mrsi performed pre-therapy for detecting high risk localized prostate cancer. outline: patients receive hyperpolarized carbon c 13 pyruvate intravenously (iv) over 10-20 seconds and undergo mrsi over 2-3 minutes at 6 and 8 weeks. after completion of study, patients are followed up at 1 day and then for up to 3 years.

Eligibility criteria:
inclusion criteria: * biopsy proven high risk prostate adenocarcinoma, or de novo metastatic previously untreated naive prostate cancer (patients who have initiated gonadotrophin releasing hormone \[lhrh\] analog or antagonist within the past 4 weeks are eligible) * gleason \>= 8 or gleason 7 + \>= ct2b + prostate specific antigen (psa) \> 10 ng/ml * prior prostate biopsy must have been performed at least 4 weeks prior exclusion criteria: * contraindication to mri * estimated glomerular filtration rate (egfr) \< 30 * allergy to gadavist intravenous contrast * history of cardiac arrhythmia * since they do not get prostate cancer, women are excluded; thus, pregnancy is not an issue
technical performance of a new cardiac technology "iq-spect" applied to scinti-ct myocardial imaging with 99mtc-sestamibi in coronary patients

Conditions: Coronary Artery Disease

Summary: cardiological examination is one of the major directions in nuclear medicine for detection of myocardial ischemia in patients with suspected coronary artery disease. in caen, they constitute 20% of the activity of nuclear medicine. it is evaluating a new versatile innovative technology (iq-spect) for performing rapid nuclear cardiological examinations (4 minutes) and quality on a scinti-ct camera for correcting the mitigation. this technical solution iq-spect was made available to the nuclear medicine department in august 2011. to date, apart from the work on heart ghosts and one publication in abstract form in 2009, no other study have been published. the goal of the study is to study the technical performance of the innovative technology iq-spect during a scinti-ct imaging in patients suspected of coronary disease .


Eligibility criteria:
inclusion criteria: * age over 18 years (except major patients under guardianship) * free and informed consent signed * written and spoken french * beneficiaries of the social security system * coronary insufficiency detection needed for patients with signs or symptoms suggestive of coronary insufficiency; or in symptomatic patients, but with a high risk of coronary heart disease: diabetes and / or with multiple cardiovascular risk factors and / or having a peripheral vascular disease exclusion criteria: * patients with a recent history (\<21 days) acute coronary failure (myocardial infarction, unstable angina); * patients with an irregular heartbeat, because of the impossibility of achieving a good quality ecg synchronization (atrial fibrillation, ventricular extra-systole or supraventricular over 25% of cardiac cycles); * patients with a pacemaker with a permanent electro-drive at rest; * patients with non-ischemic heart disease: primitive dilated cardiomyopathy, severe hypertrophic cardiomyopathy, severe valvular cardiomyopathy (aortic stenosis, aortic or mitral leakage grade\> 2), congenital heart disease; * patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment); * major patients under guardianship; * pregnant or lactating women; * women in age and condition of childbearing; * patients unable to understand the purpose of the study. cons-indications to physical stress test: * uncontrolled heart failure, * pulmonary embolism, phlebitis evolution, * myocarditis, pericarditis, endocarditis evolving * physical disability, * thrombus * asthma * contra-indication for exercise testing as dipyridamole: * severe asthma
outcomes of high power application in catheter ablation of paroxysmal atrial fibrillation guided by unipolar signal modification.

Conditions: Atrial Fibrillation Paroxysmal

Summary: pulmonary vein isolation (pvi) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (paf) \[1\]. however, the incidence of atrial fibrillation (af) recurrence remains high \[2\], mostly due to pulmonary vein (pv) reconnection \[1\], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines \[3\]. previous studies have shown that elimination of the negative component of the unipolar electrogram (up-egm) during radiofrequency applications reflects transmural lesions. the persistence of such a negative component consistently corresponds to non-trans mural lesions \[4\].

pulmonary vein isolation (pvi) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (paf) \[1\]. however, the incidence of atrial fibrillation (af) recurrence remains high \[2\], mostly due to pulmonary vein (pv) reconnection \[1\], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines \[3\]. previous studies have shown that elimination of the negative component of the unipolar electrogram (up-egm) during radiofrequency applications reflects transmural lesions. the persistence of such a negative component consistently corresponds to non-trans mural lesions \[4\]. the high-power short duration (hpsd) rf application applies to all rf energies delivered at more than 40 w \[5\]. higher the power more is the resistive heating causing wider tissue injury \[5\]. the lesion size with hpsd is larger in width but lesser in depth compared to lower powers with longer duration \[5\]. in contrast, rf applications of lower power and longer duration result in larger dissipation of rf energies deep into the tissues due to conductive heating causing tissue destruction at greater depths \[6\]. hence, there is a risk of collateral tissue damage \[5\]. hpsd ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. however, maintaining a high power for a constant duration in the absence of a guide may not be the right strategy \[5\]. unipolar waveform modification by complete elimination of the negative component may serve as a guide for hpsd ablation \[5\].

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation exclusion criteria: * age\ 80 years old, * atrium (la) diameter \> 50 mm, * the presence of a mechanical mitral valve prosthesis, * left ventricular ejection fraction \< 40%, * abnormal thyroid function, * contraindication to anticoagulant therapy, * current malignancy, * prior catheter or surgical af ablation.

Keywords: atrial fibrillation ablation - unipolar signal modification
exploratory clinical study to evaluate sodium oxybate (xyrem) on potential endocrine changes

Conditions: Narcolepsy With Cataplexy

Summary: to monitor for endocrine changes in response to treatment of cataplexy with xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of xyrem on potential endocrine changes.


Eligibility criteria:
inclusion criteria: inclusion criteria: * narcoleptic patients with cataplexy exclusion criteria: * subjects not diagnosed with narcolepsy with cataplexy exclusion criteria:

Keywords: endocrine evaluation cataplexy sodium oxybate (xyrem)
feasibility study: comparison of performance status with objective physical activity monitors

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this research is to examine the relationship between performance status rating and the actual amount of physical activity a subject does when it is measured by an activity monitor.


Eligibility criteria:
inclusion criteria: * worst daily pain rating of \< 4/10 * ecog performance status of 0, 1, or 2 * prior malignancy is allowed as long as it is inactive or well-controlled without current anti-tumor therapy required exclusion criteria: * known brain metastasis * use of assistive devices (cane, crutch) * no concurrent radiotherapy: all radiotherapy must be completed 4 weeks prior to enrollment in this study * patients receiving only targeted therapy are not eligible(e.g.erlotinib)
detecting generalized tonic-clonic seizures with a seizure detection and warning system in epilepsy patients

Conditions: Epilepsy; Generalized Tonic-Clonic Seizures

Summary: prospective study of an electromyography (emg) based seizure detection and warning system for detecting generalized tonic-clonic (gtc) seizures.

this study "a pivotal, phase iii trial of detecting generalized tonic-clonic seizures with a seizure detection and warning system in epilepsy patients " is a phase iii, pivotal, prospective study of an electromyography (emg) based seizure detection and warning system (tentatively named brain sentinel™ seizure detection system) for detecting generalized tonic-clonic (gtc) seizures. the detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a gtc seizure and provide a record of gtc seizure activity. this is to facilitate a faster intervention to the gtc seizure, and to more accurately document gtc seizure frequency in a home, skilled nursing, or inpatient setting.

Eligibility criteria:
inclusion criteria: 1. subject has a history of gtc seizures, either primary gtc or partial onset seizures with secondary generalization. 2. is being admitted to a hospital for routine veeg monitoring related to seizures. 3. male or female between the ages of 2-99. 4. has an upper arm circumference which is adequate for proper fit of the emg monitor (at least 14cm). 5. if female and of childbearing potential, has a negative pregnancy test. 6. can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments. 7. subject and/or primary caregiver must be competent to follow all study procedures. 8. is able to read, speak, and understand english. exclusion criteria: 1. does not have a documented history of generalized seizures. 2. has not had a gtc seizure within the last year and is not expected to have a reduction of anti-epileptic drugs during their hospital admission. 3. intracranial eeg electrodes are being used 4. the subject's upper arm circumference not adequate for proper fit of the emg monitor (less than 14cm). 5. pregnant female. 6. subject/caregiver is unable to provide consent.
a study of ly3039478 in japanese participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to evaluate the tolerability of the study drug ly3039478 in japanese participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. * in the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate. * performance status of ≤1 on the eastern cooperative oncology group (ecog) scale. * adequate organ function, including hematologic, hepatic, and renal. * estimated life expectancy of ≥12 weeks. exclusion criteria: * received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively. * have serious preexisting medical conditions. * have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea. * have an active bacterial, fungal, and/or known viral infection. * have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.

Keywords: notch inhibitor
nintedanib (bibf 1120) in mesothelioma

Conditions: Mesothelioma

Summary: this is a phase ii/iii confirmatory study designed to evaluate the safety and efficacy of nintedanib (bibf 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (bibf 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignant pleural mesothelioma (mpm) (epithelioid or biphasic subtype for phase ii patients; epithelioid subtype only for phase iii patients) * life expectancy of at least 3 months in the opinion of the investigator * eastern cooperative oncology group (ecog) score of 0 or 1 * measurable disease according to modified recist (response evaluation criteria in solid tumours) criteria exclusion criteria: * previous systemic chemotherapy for mpm * prior treatment with nintedanib or any other prior line of therapy * phase ii patients with sarcomatoid subtype mpm or phase iii patients with biphasic or sarcomatoid subtype mpm * patients with symptomatic neuropathy * radiotherapy (except extremities) within 3 months prior to baseline imaging * active brain metastases (e.g. stable for \< 4 weeks) * radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by mpm * significant cardiovascular diseases * inadequate hematologic, renal, or hepatic function
sstr2 imaging with [68ga]ga-dota-toc pet/ct in npc

Conditions: Nasopharyngeal Carcinoma (NPC)

Summary: this is an investigator-initiated, single-center clinical trial designed to evaluate the feasibility of \[68ga\]ga-dota-toc positron emission tomography (pet) scan in patients with epstein-barr virus (ebv) related nasopharyngeal carcinome (npc) prior to and three weeks after the start of induction chemotherapy or concurrent chemoradiotherapy (crt). archival tumor tissue from the diagnostic biopsy will be used to perform somatostatin receptor 2 (sstr2) immunohistochemistry (ihc). blood samples will be drawn at baseline, after three weeks, after completion of induction chemotherapy if applicable, and after crt.


Eligibility criteria:
inclusion criteria: * stage ib-iva npc (ajcc 9th edition), ebv positive determined by epstein-barr virus-encoded rna (eber). * planned treatment with induction chemotherapy or crt without induction chemotherapy. * age ≥ 18 years. * signed informed consent. * willingness and ability to comply with all protocol required procedures. * negative serum pregnancy test at screening in women of childbearing potential. * archival tumor tissue available or consent to undergo a tumor biopsy procedure. exclusion criteria: * previous treatment with chemotherapy or radiotherapy for npc. * treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to \[68ga\]ga-dota-toc injection. * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or that may affect the interpretation of the results or render the patient at high risk from complications. * altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * inability to lie in supine position for 25 minutes. * patients who are pregnant or breastfeeding.